QM300 IGG ANTIBODY PACK— 510(k) K871340
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K871340 for QM300 IGG ANTIBODY PACK, Substantially Equivalent on 1987-04-22. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code DEW
view allMore clearances from Kallestad Diag, A Div. of Erbamont, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.